高级注册经理 北京

月薪： 2.5-3万/月

该公司所有职位
  • 10年以上经验
  • 本科
  • 招1人
  • 01-02 发布

职位描述

Responsibilities：1.Develop and implement registration plan for new products in China within relevant therapeutic areas.2.Manage registration submissions for new products registration and clinical trial applications.3.Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.4.Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.5.Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.6.Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.7.Closely follow up regulation changes and analyze/predict its impact on company registration strategies.8.Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.9.Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.Qualifications and Experience1.Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.2.Ability to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.3.Understanding of market access needs and implementation of appropriate measures for health care purposes.4.Strong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.5.Ability to anticipate and facilitate issue resolution to meet local registration requirements.6.High leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.7.Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering high quality results and strives for continuous improvement.8.A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.9.10 years pharmaceutical industrial experience ideally; >5 year’s RA experience in pharmaceutical enterprise or CRO including more than 3 years in the project management post.10.Good knowledge of CFDA regulations and guidelines.11.Good working relationship with regulatory authorities.12.Good communication and management skill. 职能类别： 药品注册

联系方式

北京市建国门外大街中环世贸中心

公司信息

萌蒂（中国）制药有限公司（以下简称“萌蒂中国制药”），自1993年进入中国以来，始终专注在疼痛领域的规范化治疗理念的推广和产品研发与生产。目前，萌蒂中国制药是国内一家专业研发生产和推广镇痛药的跨国公司，在华拥有1500多位员工，业务遍布300多个城市。在北京拥有设备先进、国内的专业麻醉和精神类药品的生产工厂。 通过多年的不懈努力，萌蒂中国制药已成为中国癌痛领域当之无愧的领导者，并引领镇痛领域。 多年来，我们一直坚持为提高人类的生活质量和健康水平而奋斗，“健康生活，品质人生”是我们的企业愿景；关爱生命，回馈社会是我们的社会责任；创新的天赋，以患者为核心的理念以及企业家精神是我们血液中的 DNA。 未来，萌蒂中国制药将继续深耕疼痛管理领域，同时将业务进一步拓展至肿瘤、消毒用品、呼吸系统、健康消费品等全新领域。 更多公司信息，请参阅 http://www.mundipharma.com.cn

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